FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
Today, (yesterday) the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. EndeavorRx is indicated to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of condition. The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.
“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master’s of Nursing Science Degree as an Educator.
She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen – one daughter-in-law; Katie – two granddaughters; Isabella Marianna and Zoe Olivia – and one grandson, Alexander Paul. She also shares her life with her husband Gordon Duff, many cats, and two rescues.